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临床试验/NCT01241227
NCT01241227已完成不适用

Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease. A Prospective Follow-up of 4,935 Person-years

Association HGE CHU Bordeaux Sud1 个研究点 分布在 1 个国家目标入组 1,830 人开始时间: 2003年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,830
试验地点
1
主要终点
Overall survival

研究概览

简要总结

The aim of this prospective study was to compare the 5-year prognostic value of transient elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting survival and complications of cirrhosis in patients with chronic liver diseases.

详细描述

A total of 1616 patients with chronic hepatitis C was included. At 5 years, 79 patients were dead (39 liver-related deaths) and 16 patients had liver transplantation. Overall survival was 91.7% and survival without liver-related death 94.4%. Survival was significantly decreased in patients diagnosed with severe fibrosis, whatever the non-invasive method used. All these methods were able to predict a shorter survival in this large population. Patients had their prognosis decreased as liver stiffness increased. By multivariate analysis, only FibroTest > 0.74 (OR 4.41, 95%CI 1.62-12.01, p=0.004) was associated with overall survival, and liver stiffness > 9.5 kPa (OR 4.71, 95%CI 1.06-21.01, p=0.04) associated with liver-related death.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • chronic hepatitis C
  • chronic hepatitis B
  • alcoholic liver disease
  • non alcoholic steatohepatitis

排除标准

  • 未提供

结局指标

主要结局

Overall survival

时间窗: 3 months

次要结局

  • Survival without liver complications(3 months)
  • Survival without liver transplantation(3 months)

研究者

发起方
Association HGE CHU Bordeaux Sud
申办方类型
Other
责任方
Principal Investigator
主要研究者

de Ledinghen

Professor

Association HGE CHU Bordeaux Sud

研究点 (1)

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